510(k) · Cleared
ClearedVoyager Pacs System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Voyager Imaging · LLZ System, Image Processing, Radiological
Cleared on Sep 11, 2006 as substantially equivalent to K060263 (S.C. Info World S.R.L., 2006) after a 53-day review. Its family tree reaches back 4 generations to 2001. 5 later devices descend from it.
- Decided
- Sep 11, 2006
- Review
- 53 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010259 (2001). 5 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK010259 Mediface PacsMediface Co., Ltd. · 2001
- 3 generations backK012844 Marosis PacsMarotech, Inc. · 2001
- 2 generations backK040486 MedipacsNeobit Co., Ltd. · 2004
- 1 generation backK060263 IqpacsS.C. Info World S.R.L. · 2006
- This deviceK062062 Voyager Pacs SystemVoyager Imaging · 2006
- Descendant · cites it directly · 0 of its ownK102148 Curiepacs (Dicom Pacs Software)Moksha Digital Software Pvt Limited · 2010
- Descendant · cites it directly · 0 of its ownK093247 Medsynapse Pacs SoftwareMedsynaptic Private, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK082240 SntrypacsQstar Technologies, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK081752 Edge PacsAshva Technologies, Pvt., Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK071602 Imagic V2.0Ashva Technologies, Pvt., Ltd. · 2007
Most influential descendants
Showing 5 of 5 · See all- K102148Curiepacs (Dicom Pacs Software)Moksha Digital Software Pvt Limited · 2010 · cites it directly0descendants
- K093247Medsynapse Pacs SoftwareMedsynaptic Private, Ltd. · 2009 · cites it directly0descendants
- K082240SntrypacsQstar Technologies, Inc. · 2008 · cites it directly0descendants
- K081752Edge PacsAshva Technologies, Pvt., Ltd. · 2008 · cites it directly0descendants
- K071602Imagic V2.0Ashva Technologies, Pvt., Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010259 | Mediface Pacs | Mediface Co., Ltd. | 2001 | — |
| −3 | K012844 | Marosis Pacs | Marotech, Inc. | 2001 | — |
| −2 | K040486 | Medipacs | Neobit Co., Ltd. | 2004 | — |
| −1 | K060263 | Iqpacs | S.C. Info World S.R.L. | 2006 | — |
| 0 (this device) | K062062 | Voyager Pacs System | Voyager Imaging | 2006 | — |
| +1 | K102148 | Curiepacs (Dicom Pacs Software) | Moksha Digital Software Pvt Limited | 2010 | — |
| +1 | K093247 | Medsynapse Pacs Software | Medsynaptic Private, Ltd. | 2009 | — |
| +1 | K082240 | Sntrypacs | Qstar Technologies, Inc. | 2008 | — |
| +1 | K081752 | Edge Pacs | Ashva Technologies, Pvt., Ltd. | 2008 | — |
| +1 | K071602 | Imagic V2.0 | Ashva Technologies, Pvt., Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060263 | IqpacsSummary page 1…tem is substantially equivalent to: Manufacturer: S.C. INFO WORLD S.R.L Device Name: IQPACS 510(k) Number: K060263 Decision Date: 03/15/2006 Decision: Substantially Equivalent Product Code:… | 2006 |
What descends from it? (5)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K102148 (Moksha Digital Software Pvt Limited, 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
Voyager PACS System' TM is a software based device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.). Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed…
Read the full statement (106 words)
Voyager PACS System' TM is a software based device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.). Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062062: Voyager Pacs System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062062
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026